Fuzheng Huayu Tablets for Metabolic Dysfunction-Associated Fatty Liver Cirrhosis (Compensated): A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study
459 participantsStarted 2026-05-25
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Fuzheng Huayu Tablets in patients with metabolic dysfunction-associated fatty liver cirrhosis (compensated). Eligible patients will be randomly assigned to receive either Fuzheng Huayu Tablets or placebo for 72 weeks. The primary objective is to assess the improvement in liver fibrosis, measured by liver stiffness reduction via FibroScan. Secondary objectives include changes in liver function indicators, liver fibrosis markers, Child-Pugh score, and safety profile.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 to 75 years (inclusive of both upper and lower limits).
. Diagnosed with compensated metabolic dysfunction-associated fatty liver cirrhosis, meeting all three of the following conditions:
Exclusion criteria
. History or current hepatic decompensation events at screening, including but not limited to the following: a) Esophagogastric variceal bleeding; b) Hepatic ascites requiring diuretic treatment; c) Hepatic encephalopathy (West Haven grade 2 or above); d) Hepatorenal syndrome.
. Having a history or evidence of other chronic liver diseases, such as alcoholic liver disease, drug-induced liver disease, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis, history of biliary obstruction or biliary shunt, metastatic liver cancer; Hepatitis B (HBsAg positive); Hepatitis C (HCV antibody positive and HCV-RNA positive). Subjects with previous hepatitis C treatment must maintain negative HCV-RNA results for at least 3 years before screening to be eligible.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Patients with ≥20% Reduction in Liver Stiffness Measurement (LSM) at Week 72 Compared to Baseline
Timeframe: Week 72
2
Proportion of Patients with ≥20% Reduction in Liver Stiffness Measurement (LSM) at Week 72 Compared to Baselin
Timeframe: week72
Trial details
NCT IDNCT07663643
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
. History of liver transplantation, on the liver transplantation waiting list, or history of TIPS operation.
. Use of anti-obesity drugs within 3 months prior to screening and during the whole trial is prohibited, including bupropion-naltrexone, orlistat, phentermine, phentermine/topiramate and anti-obesity supplements. Subjects planning to receive metabolic bariatric surgery during the study will be excluded (excluding acupuncture weight loss, liposuction or abdominal lipectomy performed more than 1 year before screening).
. Type 1 diabetes mellitus; uncontrolled type 2 diabetes mellitus, defined as HbA1c \> 9% at screening or within 60 days before randomization. Subjects with HbA1c \> 9% may be re-screened once no less than 3 months after the initial screening failure; insulin dosage adjustment more than 20% within 60 days before randomization is also excluded.
. Unstable use of drugs that may affect efficacy evaluation within 3 months prior to screening, including but not limited to Vitamin E (dose \> 400 IU/d), thiazolidinediones (TZDs), SGLT-2 inhibitors, GLP-1 receptor agonists, and chiglitazar. Those who have taken stable dosage continuously until screening visit and will maintain relatively stable dosage throughout the study period are allowed to enroll.
. Use of drugs that may induce hepatic steatosis or steatohepatitis for at least 4 weeks within 6 months prior to screening (e.g., valproic acid, tamoxifen, methotrexate, amiodarone, long-term oral corticosteroids \> 5 mg/d prednisone equivalent, or estrogen at doses higher than contraception or hormone replacement therapy). The above drugs are prohibited throughout the trial until the end of follow-up. Subjects requiring bronchodilators, topical, inhaled, nasal corticosteroids or caudal steroid injections are not excluded.
. Use of Chinese herbal medicine and proprietary Chinese medicines with anti-fibrotic or MAFLD therapeutic effects within 3 months prior to screening, including but not limited to Compound Biejia Ruangan Capsules, Anluo Huaxian Pills, Qianggan Capsules/Tablets. If the medication course is no more than 3 months, subjects can be enrolled after a 1-month washout period.